Senior Benefit Risk Evaluation Assessor (x2 posts)

The Medicines And Healthcare Products Regulatory Agency - Benefit/Risk Evaluation Team II Function / Safety and Surveillance group.

The MHRA is transforming. Through enabling innovation, making the right judgements of the benefits and risks of medical products and forging the right partnerships in the UK and internationally, it aims to deliver world class regulation and improved outcomes for UK patients.

We are currently looking for experienced Senior Benefit Risk Evaluation Assessor – Musculoskeletal, Trauma and Cosmetic and a Senior Benefit Risk Evaluation Assessor – Cardiovascular and Fluid Management to join our Benefit/Risk Evaluation Team II Function within the Safety and Surveillance group.

Within a week of working here, your day could look like this: provide a robust benefit risk assessment of potential safety signals within the therapeutic areas using data from a range of sources and technical, scientific, clinical and regulatory knowledge and/or practical experience. Benefit risk assessors are responsible for engaging with a range of stakeholders including patients and the public to make timely and robust benefit-risk assessments and recommend safety actions and risk mitigations that are outcome focused.

The Benefit risk assessor will help deliver on our ongoing work and increase capacity to respond to new-emerging safety issues. They will have comprehensive medicine and/or medical device regulatory experience as well as professional, technical or scientific expertise in the relevant therapeutic areas.

The experience of the successful applicant will be vital in helping to support new members of the team build their competencies.

All benefit risk roles require working flexibly to perform and contribute to benefit risk assessments across all medical products as required.

The successful candidates will have a degree in a relevant health, scientific or engineering discipline e.g. medicine, biochemistry, physiology, medical engineering or regulation.

Our successful candidate will:

• Have comprehensive experience in critically analysing clinical/scientific information from a range of sources including case reports, registries, clinical trials/investigations, and observational studies, make sound judgements for recommendations to protect patient safety and public health.
• Have in depth knowledge of national and European/International medicine and/or medical device regulations and procedures aligned to the MHRA role in Benefit Risk Evaluation
• Have In depth knowledge of medical products in either the musculoskeletal, trauma and cosmetic or the cardiovascular and fluid management therapeutic area.
• Have excellent interpersonal skills to facilitate team-working/team-leading, consulting and co-operating with colleagues from different disciplines and with variable degrees of expertise
• Share knowledge to improve the capability of the team, benefit risk evaluation group and the wider safety and surveillance function.